A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of BI 1291583 2.5 mg Administered Once Daily for up to 76 Weeks in Patients With Bronchiectasis (The AIRTIVITY® Study)

Status: Recruiting
Location: See all (508) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study is open to adults with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants complete a daily diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1 % per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the participant information.

• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation.

• Age of participants when signing the informed consent ≥18 (at least the legal age of consent in countries where it is greater than 18 years) years.

• Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by Computed Tomography (CT) scan. Participants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years.

• Participants should be able to produce sputum for screening.

• History of documented pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either:

‣ at least 2 exacerbations, or

⁃ at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \>40 at screening Visit 1 For participants on stable oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of stable antibiotics or CFTR-MT.

Locations
United States
Alaska
Providence Medical Group Alaska
NOT_YET_RECRUITING
Anchorage
Alabama
University of Alabama at Birmingham
NOT_YET_RECRUITING
Birmingham
Arizona
Dignity Health, St. Joseph's Hospital and Medical Center
NOT_YET_RECRUITING
Phoenix
University of Arizona
NOT_YET_RECRUITING
Tucson
California
Newport Native MD, Inc
RECRUITING
Newport Beach
Paradigm Clinical Research - Redding
RECRUITING
Redding
University of California Davis
NOT_YET_RECRUITING
Sacramento
Ventura County Medical Center
NOT_YET_RECRUITING
Ventura
Colorado
National Jewish Health
NOT_YET_RECRUITING
Denver
Connecticut
Yale University School of Medicine
NOT_YET_RECRUITING
New Haven
Washington, D.c.
Georgetown University
NOT_YET_RECRUITING
Washington D.c.
Florida
Central Florida Pulmonary Group
NOT_YET_RECRUITING
Altamonte Springs
Meris Clinical Research-Brandon-69466
NOT_YET_RECRUITING
Brandon
St. Francis Medical Institute
RECRUITING
Clearwater
Malcom Randall VA Medical Center
NOT_YET_RECRUITING
Gainesville
Mayo Clinic - Florida
NOT_YET_RECRUITING
Jacksonville
University of Florida College of Medicine
NOT_YET_RECRUITING
Jacksonville
University of Miami
NOT_YET_RECRUITING
Miami
Essence MD Research
RECRUITING
Naples
Premier Medical Associates
NOT_YET_RECRUITING
The Villages
Cleveland Clinic Florida
NOT_YET_RECRUITING
Weston
Georgia
Emory University
NOT_YET_RECRUITING
Atlanta
Augusta University
NOT_YET_RECRUITING
Augusta
Iowa
University of Iowa Hospitals and Clinics
NOT_YET_RECRUITING
Iowa City
Illinois
Northwestern University
NOT_YET_RECRUITING
Chicago
Indiana
Indiana University
NOT_YET_RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center
NOT_YET_RECRUITING
Kansas City
Massachusetts
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
UMASS Memorial Medical Center
NOT_YET_RECRUITING
Worcester
Maryland
Johns Hopkins University
NOT_YET_RECRUITING
Baltimore
University of Maryland St. Joseph Medical Group Pulmonary Care and Sleep Medicine
NOT_YET_RECRUITING
Towson
Michigan
University of Michigan Health System
NOT_YET_RECRUITING
Ann Arbor
Minnesota
Mayo Clinic, Rochester
NOT_YET_RECRUITING
Rochester
Health Partners Specialty
NOT_YET_RECRUITING
Saint Paul
Missouri
The Lung Research Center, LLC
NOT_YET_RECRUITING
Chesterfield
SSM Health Cardinal Glennon Children's Hospital
NOT_YET_RECRUITING
St Louis
Washington University School of Medicine
NOT_YET_RECRUITING
St Louis
Mississippi
University Of Mississippi Medical Center
NOT_YET_RECRUITING
Jackson
North Carolina
The University of North Carolina at Chapel Hill
NOT_YET_RECRUITING
Chapel Hill
Stern Research Partners, LLC
NOT_YET_RECRUITING
Huntersville
Pinehurst Medical Clinic, Inc. - East
NOT_YET_RECRUITING
Pinehurst
Nebraska
University of Nebraska Medical Center
NOT_YET_RECRUITING
Omaha
New Hampshire
Dartmouth-Hitchcock Medical Center
NOT_YET_RECRUITING
Lebanon
New Jersey
Rutgers Robert Wood Johnson Medical School
NOT_YET_RECRUITING
New Brunswick
New York
New York Medical College - Hawthorne
NOT_YET_RECRUITING
Hawthorne
Northwell Health
NOT_YET_RECRUITING
New Hyde Park
Columbia University Medical Center-New York Presbyterian Hospital
NOT_YET_RECRUITING
New York
Icahn School of Medicine at Mount Sinai
NOT_YET_RECRUITING
New York
NewYork-Presbyterian/Weill Cornell Medical Center
NOT_YET_RECRUITING
New York
NYU Langone Health
NOT_YET_RECRUITING
New York
Ohio
Akron Children's Hospital
NOT_YET_RECRUITING
Akron
University of Cincinnati
NOT_YET_RECRUITING
Cincinnati
University Hospitals of Cleveland
NOT_YET_RECRUITING
Cleveland
ProMedica Physicians Pulmonary and Sleep Medicine - Toledo
NOT_YET_RECRUITING
Toledo
Oregon
Summit Health
NOT_YET_RECRUITING
Bend
Oregon Health and Sciences University
NOT_YET_RECRUITING
Portland
Pennsylvania
Clinical Research Associates of Central PA
RECRUITING
Dubois
Jefferson Health Honickman Center
NOT_YET_RECRUITING
Philadelphia
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina
NOT_YET_RECRUITING
Charleston
Clinical Research of Rock Hill
NOT_YET_RECRUITING
Rock Hill
Texas
Horizon Clinical Research Group
RECRUITING
Cypress
University of Texas Southwestern Medical Center
NOT_YET_RECRUITING
Dallas
El Paso Pulmonary Association
NOT_YET_RECRUITING
El Paso
University of Texas Medical Branch at Galveston
NOT_YET_RECRUITING
Galveston
Metroplex Pulmonary & Sleep Center
RECRUITING
Mckinney
Element Research Group
NOT_YET_RECRUITING
San Antonio
Methodist Heart and Lung Institute
NOT_YET_RECRUITING
San Antonio
UT Health San Antonio
NOT_YET_RECRUITING
San Antonio
University of Texas Health Science Center at Tyler
NOT_YET_RECRUITING
Tyler
Utah
Intermountain Healthcare
NOT_YET_RECRUITING
Murray
Virginia
Inova Fairfax Medical Campus
NOT_YET_RECRUITING
Falls Church
Virginia Commonwealth University Health Systems
NOT_YET_RECRUITING
Richmond
Vermont
University of Vermont
NOT_YET_RECRUITING
Colchester
Washington
University of Washington
NOT_YET_RECRUITING
Seattle
Providence Medical Research Center
NOT_YET_RECRUITING
Spokane
Wisconsin
University of Wisconsin
NOT_YET_RECRUITING
Madison
Froedtert and The Medical College of Wisconsin
NOT_YET_RECRUITING
Milwaukee
Other Locations
Argentina
Centro Dr. Lazaro Langer S.R.L
NOT_YET_RECRUITING
Alberdi Sur
Centro de Enfermedades Cardiovasculares (CEC)
NOT_YET_RECRUITING
Bahía Blanca
CEDIC - Centro de Investigacion Clinica
NOT_YET_RECRUITING
Caba
Centro de Investigación Clinica Belgrano
NOT_YET_RECRUITING
Caba
Equipo Ciencia
NOT_YET_RECRUITING
Caba
Hospital Aleman
NOT_YET_RECRUITING
Caba
Mautalen- Salud e Investigacion
NOT_YET_RECRUITING
Caba
APRILLUS-Asistencia e Investigacion
NOT_YET_RECRUITING
Ciudad Autonoma Buenos Aires
Instituto Ave Pulmo
NOT_YET_RECRUITING
Mar Del Plata
Centro Respiratorio de Quilmes
NOT_YET_RECRUITING
Quilmes
Instituto de Especialidades de la Salud Rosario
NOT_YET_RECRUITING
Rosario
Ibamedica
NOT_YET_RECRUITING
Santa Fe
Australia
Eastern Health-Box Hill Hospital
NOT_YET_RECRUITING
Box Hill
Royal Prince Alfred Hospital
NOT_YET_RECRUITING
Camperdown
Heart of Australia Research Institute
RECRUITING
Chelmer
Lung Research Queensland
NOT_YET_RECRUITING
Chermside
The Prince Charles Hospital
NOT_YET_RECRUITING
Chermside
Concord Repatriation General Hospital
NOT_YET_RECRUITING
Concord
Peninsula Health
NOT_YET_RECRUITING
Frankston
Canberra Hospital
NOT_YET_RECRUITING
Garran
Greenslopes Private Hospital
NOT_YET_RECRUITING
Greenslopes
Alfred Hospital
NOT_YET_RECRUITING
Melbourne
Institute for Respiratory Health
NOT_YET_RECRUITING
Nedlands
Macquarie University
NOT_YET_RECRUITING
North Ryde
The Royal Children's Hospital
NOT_YET_RECRUITING
Parkville
Mater Hospital Brisbane
NOT_YET_RECRUITING
South Brisbane
Queensland Children's Hospital
NOT_YET_RECRUITING
South Brisbane
Trialswest
RECRUITING
Spearwood
Westmead Hospital
NOT_YET_RECRUITING
Westmead
Austria
Medical University of Graz State Hospital - University Hospital Graz
NOT_YET_RECRUITING
Graz
Medical University of Innsbruck
NOT_YET_RECRUITING
Innsbruck
Hospital Hietzing
NOT_YET_RECRUITING
Vienna
Klinikum Wels - Grieskirchen GmbH
NOT_YET_RECRUITING
Wels
Belgium
Cliniques Universitaires Saint-Luc
NOT_YET_RECRUITING
Brussels
UNIV UZ Gent
NOT_YET_RECRUITING
Ghent
UZ Leuven
NOT_YET_RECRUITING
Leuven
Vitaz - Campus Sint-Niklaas
NOT_YET_RECRUITING
Sint-niklaas
Brazil
Serviços Medicos Respirar Sul Fluminense
NOT_YET_RECRUITING
Barra Mansa
Faculdade de Medicina de Botucatu - UNESP
NOT_YET_RECRUITING
Botucatu
Chronos Pesquisa Clinica
NOT_YET_RECRUITING
Brasília
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
NOT_YET_RECRUITING
Goiânia
Hospital Universitário Lauro Wanderley
NOT_YET_RECRUITING
João Pessoa
Irmandade da Santa Casa de Misericórdia de Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
Netspiro Clinica Medica Ltda - Respsono
NOT_YET_RECRUITING
São Bernardo Do Campo
INCOR e Hospital das Clínicas da Universidade de São Paulo
NOT_YET_RECRUITING
São Paulo
Bulgaria
MHAT Rahila Angelova AD
NOT_YET_RECRUITING
Pernik
Medical Center Unimed
NOT_YET_RECRUITING
Plovdiv
SHATPPD Dr. Dimitar Gramatikov
NOT_YET_RECRUITING
Rousse
Diagnostics And Consultation Center Convex Ltd.
NOT_YET_RECRUITING
Sofia
Medical Center Pulmovision
NOT_YET_RECRUITING
Sofia
Medical Center Tara
NOT_YET_RECRUITING
Veliko Tarnovo
Medical Center Sveti Ivan Rilski
NOT_YET_RECRUITING
Vidin
Sbalpfz-Vratsa
NOT_YET_RECRUITING
Vratsa
Canada
BLC Clinical Research
NOT_YET_RECRUITING
Burlington
University of Calgary
NOT_YET_RECRUITING
Calgary
QEII Health Sciences Centre
NOT_YET_RECRUITING
Halifax
Centre Hospitalier de l'Universite de Montreal (CHUM)
NOT_YET_RECRUITING
Montreal
IUCPQ (Laval University)
NOT_YET_RECRUITING
Québec
Royal University Hospital (Saskatoon)
NOT_YET_RECRUITING
Saskatoon
Diex Recherche (Sherbrooke)
NOT_YET_RECRUITING
Sherbrooke
Diex Recherche (Trois-Rivieres)
NOT_YET_RECRUITING
Trois-rivières
St. Paul's Hospital (Vancouver)
NOT_YET_RECRUITING
Vancouver
Cardio 1 Medical Clinic
RECRUITING
Winnipeg
Chile
Centro de Estudios Clínicos CEC
NOT_YET_RECRUITING
Santiago
Centro de Investigación del Maule
NOT_YET_RECRUITING
Talca
China
China-Japan Friendship Hospital
NOT_YET_RECRUITING
Beijing
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
Peking University People's Hospital
NOT_YET_RECRUITING
Beijing
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The Second Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The Second Xiangya Hospital Of Central South University
NOT_YET_RECRUITING
Changsha
People's Hospital of Sichuan Province
NOT_YET_RECRUITING
Chengdu
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Guizhou People's Hospital
NOT_YET_RECRUITING
Guiyang
Hangzhou First People's Hospital
RECRUITING
Hangzhou
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University
NOT_YET_RECRUITING
Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Zhejiang Hospital
RECRUITING
Hangzhou
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
Huzhou Central Hospital
RECRUITING
Huzhou
Jiangmen Central Hospital
NOT_YET_RECRUITING
Jiangmen
The First Affiliated Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
The Second Affiliated Hospital to Nanchang University
NOT_YET_RECRUITING
Nanchang
Nanjing Drum Tower Hospital
NOT_YET_RECRUITING
Nanjing
Nanjing First Hospital
NOT_YET_RECRUITING
Nanjing
Affiliated Hospital of Nantong University
NOT_YET_RECRUITING
Nantong
Ningbo Medical Center Lihuili Hospital
RECRUITING
Ningbo
The First Affiliated Hospital of Ningbo University
NOT_YET_RECRUITING
Ningbo
Pingxiang People's Hospital
NOT_YET_RECRUITING
Pingxiang
Qingdao Municipal Hospital
NOT_YET_RECRUITING
Qingdao
The Second Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING
Quanzhou
Huadong Hospital affiliated to Fudan University
RECRUITING
Shanghai
Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
NOT_YET_RECRUITING
Shanghai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Shanghai Fifth People's Hospital affiliated to Fudan University
RECRUITING
Shanghai
Shanghai General Hospital
RECRUITING
Shanghai
Shanghai Pulmonary Hospital
NOT_YET_RECRUITING
Shanghai
Tongji Hospital, Tongji University
NOT_YET_RECRUITING
Shanghai
Zhongshan Hospital Affiliated to Fudan University
NOT_YET_RECRUITING
Shanghai
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Shenzhen People's Hospital
NOT_YET_RECRUITING
Shenzhen
Suining Central Hospital
NOT_YET_RECRUITING
Suining
The First Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Tianjin Medical University General Hospital
NOT_YET_RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Wenzhou People's Hospital
RECRUITING
Wenzhou
Wuhan Union Hospital
RECRUITING
Wuhan
Wuxi People's Hospital
RECRUITING
Wuxi
First Affiliated Hospital of Xi'an JiaoTong University
NOT_YET_RECRUITING
Xi'an
Affiliated Hospital, Xuzhou Medical college
RECRUITING
Xuzhou
Northern Jiangsu People's Hospital
NOT_YET_RECRUITING
Yangzhou
Yixing People'S Hospital
NOT_YET_RECRUITING
Yixing
Croatia
Specialty Hospital Medico
NOT_YET_RECRUITING
Rijeka
Clinical Hospital Centar Sestre Milosrdnice
NOT_YET_RECRUITING
Zagreb
Clinical Hospital Centre Zagreb
NOT_YET_RECRUITING
Zagreb
Denmark
Aalborg Sygehus Syd
NOT_YET_RECRUITING
Aalborg
Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus N
Hvidovre Hospital
NOT_YET_RECRUITING
Hvidovre
Copenhagen University Hospital, Rigshospitalet
NOT_YET_RECRUITING
København Ø
Vejle University Hospital
NOT_YET_RECRUITING
Vejle
Egypt
CRC-Alexandria University
NOT_YET_RECRUITING
Alexandria
Ain Shams University Clinical Research Center (MASRI)
NOT_YET_RECRUITING
Cairo
Air Force Specialized Hospital
NOT_YET_RECRUITING
Cairo
Kasr Al Aini, Cairo University
NOT_YET_RECRUITING
Cairo
Finland
Helsinki University Hospital
NOT_YET_RECRUITING
Helsinki
Oulun yliopistollinen keskussairaala
NOT_YET_RECRUITING
Oulu
Tampere University Hospital
NOT_YET_RECRUITING
Tampere
Turku University Hospital / TYKS
NOT_YET_RECRUITING
Turku
France
HOP Amiens-Picardie Sud
NOT_YET_RECRUITING
Amiens
HOP Intercommunal
NOT_YET_RECRUITING
Créteil
INS Coeur Poumon
NOT_YET_RECRUITING
Lille
HOP Croix-Rousse
NOT_YET_RECRUITING
Lyon
HOP Arnaud de Villeneuve
NOT_YET_RECRUITING
Montpellier
HOP Pasteur
NOT_YET_RECRUITING
Nice
HOP Cochin
NOT_YET_RECRUITING
Paris
HOP Haut-Lévêque
NOT_YET_RECRUITING
Pessac
HOP Pontchaillou
NOT_YET_RECRUITING
Rennes
HOP Nord Laennec
NOT_YET_RECRUITING
Saint-herblain
HOP Larrey
NOT_YET_RECRUITING
Tououse
Germany
Universitätsklinikum Aachen, AöR
NOT_YET_RECRUITING
Aachen
Velocity Clinical Research Germany GmbH, Ahrensburg
NOT_YET_RECRUITING
Ahrensburg
CIMS Studienzentrum Bamberg GmbH
NOT_YET_RECRUITING
Bamberg
Charite Universitätsmedizin Berlin KöR
RECRUITING
Berlin
Charite Universitätsmedizin Berlin KöR
NOT_YET_RECRUITING
Berlin
Evangelische Lungenklinik Berlin
NOT_YET_RECRUITING
Berlin
Vivantes Netzwerk für Gesundheit GmbH
NOT_YET_RECRUITING
Berlin
Katholisches Klinikum Bochum gGmbH
NOT_YET_RECRUITING
Bochum
Universitätsklinikum Bonn AöR
NOT_YET_RECRUITING
Bonn
Augustiner Krankenhäuser GmbH
RECRUITING
Cologne
Universitätsklinikum Köln (AöR)
NOT_YET_RECRUITING
Cologne
Caritas-Krankenhaus St. Maria gGmbH
NOT_YET_RECRUITING
Donaustauf
Klinikum Dortmund gGmbH
NOT_YET_RECRUITING
Dortmund
Technische Universität Dresden
NOT_YET_RECRUITING
Dresden
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
RECRUITING
Essen
IKF Pneumologie GmbH & Co. KG
RECRUITING
Frankfurt
Universitätsklinikum Frankfurt
NOT_YET_RECRUITING
Frankfurt
Universitätsklinikum Freiburg
NOT_YET_RECRUITING
Freiburg Im Breisgau
Asklepios Fachkliniken München-Gauting
NOT_YET_RECRUITING
Gauting
Krankenhaus Martha-Maria Halle-Dölau gGmbH
NOT_YET_RECRUITING
Halle
Martin-Luther-Universität Halle-Wittenberg
NOT_YET_RECRUITING
Halle
Medizinische Hochschule Hannover
NOT_YET_RECRUITING
Hanover
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
NOT_YET_RECRUITING
Heidelberg
Lungenfachklinik Immenhausen
RECRUITING
Immenhausen
Universitätsklinikum Jena
RECRUITING
Jena
Universitätsklinikum Schleswig-Holstein, Campus Kiel
NOT_YET_RECRUITING
Kiel
Velocity Clinical Research Germany GmbH, Lübeck
NOT_YET_RECRUITING
Lübeck
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
NOT_YET_RECRUITING
Mainz
Klinikum der Universität München AÖR
NOT_YET_RECRUITING
München
Lungenheilkunde München-Pasing
NOT_YET_RECRUITING
München
Universitätsklinikum Münster
NOT_YET_RECRUITING
Münster
Klinikum Westbrandenburg GmbH
NOT_YET_RECRUITING
Potsdam
Helios Hanseklinikum Stralsund
NOT_YET_RECRUITING
Stralstund
BAG Wiesbaden
RECRUITING
Wiesbaden
Greece
Athens Naval Hospital
NOT_YET_RECRUITING
Athens
Chest Hospital of Athens Sotiria
NOT_YET_RECRUITING
Athens
University General Hospital of Heraklion
NOT_YET_RECRUITING
Heraklion, Crete
Univ. Gen. Hosp. of Patras
NOT_YET_RECRUITING
Pátrai
General Hospital of Thessaloniki G. Papanikolaou
NOT_YET_RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Prince of Wales Hospital-Hong Kong-20715
NOT_YET_RECRUITING
Hong Kong
Queen Mary Hospital
RECRUITING
Hong Kong
Hungary
Koranyi National Institute For Pulmonolgy
NOT_YET_RECRUITING
Budapest
Da Vinci Private Clinic
NOT_YET_RECRUITING
Pécs
India
Jawahar Lal Nehru Medical College
NOT_YET_RECRUITING
Ajmer
M. S. Ramaiah Institute of Health Science
NOT_YET_RECRUITING
Bengaluru
Narayana Health - Mazumdar Shaw Medical Center
NOT_YET_RECRUITING
Bengaluru
B. P. Poddar Hospital and Medical Research Limited
NOT_YET_RECRUITING
Kolkata
Midland Healthcare & Research Center
NOT_YET_RECRUITING
Lucknow
Siddhi Hospital, C/o Dr. Mutha Hospital
NOT_YET_RECRUITING
Nashik
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
NOT_YET_RECRUITING
Rohtak
Government Hospital for Chest and Communicable Diseases (GHCCD)
NOT_YET_RECRUITING
Visakhapatnam
Ireland
Cork University Hospital
NOT_YET_RECRUITING
Cork
Connolly Hospital Blanchardstown
NOT_YET_RECRUITING
Dublin
St. Vincent's University Hospital
NOT_YET_RECRUITING
Dublin
Israel
Lady Davis Carmel Medical Center
NOT_YET_RECRUITING
Haifa
Hadassah Medical Center, Ein-Karem
NOT_YET_RECRUITING
Jerusalem
Hadassah Medical Center, Ein-Karem
NOT_YET_RECRUITING
Jerusalem
Rabin Medical Center Beilinson
NOT_YET_RECRUITING
Petah Tikva
Italy
Azienda Ospedaliero Universitaria delle Marche
NOT_YET_RECRUITING
Ancona
Policlinico S. Orsola-Malpighi
NOT_YET_RECRUITING
Bologna
AOU Policlinico G. Rodolico San Marco
NOT_YET_RECRUITING
Catania
Azienda Ospedaliera San Martino
NOT_YET_RECRUITING
Genova
Istituto G. Gaslini
NOT_YET_RECRUITING
Genova
A.O.U.Policlinico G.Martino
NOT_YET_RECRUITING
Messina
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milan
Azienda Socio Sanitaria Territoriale Di Monza
NOT_YET_RECRUITING
Monza (mb)
A.O. dei Colli
NOT_YET_RECRUITING
Napoli
AOU San Luigi Gonzaga
NOT_YET_RECRUITING
Orbassano (to)
Azienda Ospedaliera Universitaria di Padova
NOT_YET_RECRUITING
Padua
Policlinico Paolo Giaccone
NOT_YET_RECRUITING
Palermo
Fondazione IRCCS Policlinico S. Matteo
NOT_YET_RECRUITING
Pavia
Osp. Pediatrico Bambin Gesù
NOT_YET_RECRUITING
Roma
Istituto Clinico Humanitas
NOT_YET_RECRUITING
Rozzano (mi)
Azienda Ospedaliera Universitaria Integrata Verona
NOT_YET_RECRUITING
Verona
Japan
Nagoya University Hospital
NOT_YET_RECRUITING
Aichi, Nagoya
Hirosaki University Hospital
NOT_YET_RECRUITING
Aomori, Hirosaki
Chiba University Hospital
NOT_YET_RECRUITING
Chiba, Chiba
Kameda Clinic
NOT_YET_RECRUITING
Chiba, Kamogawa
Fukuoka University Hospital
NOT_YET_RECRUITING
Fukuoka, Fukuoka
Kyushu University Hospital
NOT_YET_RECRUITING
Fukuoka, Fukuoka
Aso Co.,Ltd Iizuka Hospital
NOT_YET_RECRUITING
Fukuoka, Iizuka
Hokkaido University Hospital
NOT_YET_RECRUITING
Hokkaido, Sapporo
Terada Clinic, Respiratory Medicine & General practice
NOT_YET_RECRUITING
Hyogo, Himeji
University of Tsukuba Hospital
NOT_YET_RECRUITING
Ibaraki, Tsukuba
Kagoshima University Hospital
NOT_YET_RECRUITING
Kagoshima, Kagoshima
Kanagawa Cardiovascular and Respiratory Center
NOT_YET_RECRUITING
Kanagawa, Yokohama
Minami Kyoto Hospital
NOT_YET_RECRUITING
Kyoto, Joyo
Kyoto University Hospital
NOT_YET_RECRUITING
Kyoto, Kyoto
Matsusaka City Hospital
RECRUITING
Mie, Matsusaka
Tohoku University Hospital
NOT_YET_RECRUITING
Miyagi, Sendai
Nagasaki University Hospital
NOT_YET_RECRUITING
Nagasaki, Nagasaki
Niigata University Medical and Dental Hospital
NOT_YET_RECRUITING
Niigata, Niigata
Oita University Hospital
NOT_YET_RECRUITING
Oita, Yufu
Kurashiki Central Hospital
NOT_YET_RECRUITING
Okayama, Kurashiki
National Hospital Organization Kinki-Chuo Chest Medical Center
NOT_YET_RECRUITING
Osaka, Sakai
Osaka Toneyama Medical Center
RECRUITING
Osaka, Toyonaka
Saga University Hospital
RECRUITING
Saga, Saga
Saitama Cardiovascular and Respiratory Center
NOT_YET_RECRUITING
Saitama, Kumagaya
Shiga University of Medical Science Hospital
NOT_YET_RECRUITING
Shiga, Otsu
Matsue Medical Center
NOT_YET_RECRUITING
Shimane, Matsue
Hamamatsu University Hospital
NOT_YET_RECRUITING
Shizuoka, Hamamatsu
Tenryu Hospital
NOT_YET_RECRUITING
Shizuoka, Hamamatsu
Tokushima University Hospital
RECRUITING
Tokushima, Tokushima
Institute of Science Tokyo Hospital
NOT_YET_RECRUITING
Tokyo, Bunkyo-ku
Nihon University Itabashi Hospital
NOT_YET_RECRUITING
Tokyo, Itabashi-ku
Fukujuji Hospital
RECRUITING
Tokyo, Kiyose
Toranomon Hospital
NOT_YET_RECRUITING
Tokyo, Minato-ku
Keio University Hospital
NOT_YET_RECRUITING
Tokyo, Shinjuku-ku
Tokyo Women's Medical University Hospital
NOT_YET_RECRUITING
Tokyo, Shinjuku-ku
Yamaguchi University Hospital
NOT_YET_RECRUITING
Yamaguchi, Ube
Kazakhstan
Multidisciplinary City Hospital №1 of the Akimat of Astana
NOT_YET_RECRUITING
Astana
Latvia
Daugavpils Regional Hospital LTD Centre Outpatient Clinic
NOT_YET_RECRUITING
Daugavpils
Med.Center OLVI Health Center Assotiation,Private Practice
NOT_YET_RECRUITING
Daugavpils
VCA Dubultu Medical center
NOT_YET_RECRUITING
Jūrmala
LUMPII Doctors practice
NOT_YET_RECRUITING
Riga
Pauls Stradins Clinical University Hospital
RECRUITING
Riga
Riga 1st Hospital
NOT_YET_RECRUITING
Riga
Riga East University Hospital
NOT_YET_RECRUITING
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
NOT_YET_RECRUITING
Kaunas
Republic Klaipeda Hospital
NOT_YET_RECRUITING
Klaipėda
Inmedica
NOT_YET_RECRUITING
Vilnius
Vilnius University Hospital, Santariskiu
NOT_YET_RECRUITING
Vilnius
Malaysia
Hospital Sultanah Bahiyah
NOT_YET_RECRUITING
Alor Setar, Kedah
Hospital Sultan Idris Shah Serdang
NOT_YET_RECRUITING
Kajang
Hospital Raja Perempuan Zainab II, Kota Bharu
NOT_YET_RECRUITING
Kelantan
Institut Perubatan Respiratori
NOT_YET_RECRUITING
Kuala Lumpur
University of Malaya Medical Centre
NOT_YET_RECRUITING
Kuala Lumpur
Sarawak General Hospital
NOT_YET_RECRUITING
Kuching
Mexico
Centro de Investigacion Integral MEDIVEST S.C
NOT_YET_RECRUITING
Chihuahua City
Mediadvance Clinical S.A.P.I de C.V.
NOT_YET_RECRUITING
Chihuahua City
Centro de Investigacion Farmacologica del Bajío, S.C.
NOT_YET_RECRUITING
León
Soluciones terapeuticas medico quirurgicas S de RL de CV
NOT_YET_RECRUITING
Mexico City
Hospital Universitario Dr Jose Eleuterio Gonzalez
NOT_YET_RECRUITING
Monterrey
Hospital Universitario Dr Jose Eleuterio Gonzalez
NOT_YET_RECRUITING
Nuevo León
Oaxaca Site Management Organization, S.C.
NOT_YET_RECRUITING
Oaxaca City
Asociación Mexicana para la Investigacion Clínica, A.C(AMIC)
NOT_YET_RECRUITING
Pachuca
Clinical Research Institute S.C.
NOT_YET_RECRUITING
Tlalnepantla
Arke SMO S.A. de C.V.
NOT_YET_RECRUITING
Veracruz De Ignacio De La Llave
Netherlands
Noordwest Ziekenhuisgroep
NOT_YET_RECRUITING
Alkmaar
Amsterdam UMC Locatie VUMC
NOT_YET_RECRUITING
Amsterdam
Radboud Universitair Medisch Centrum
NOT_YET_RECRUITING
Nijmegen
Erasmus Medisch Centrum-ROTTERDAM-50697
NOT_YET_RECRUITING
Rotterdam
Haga Ziekenhuis
NOT_YET_RECRUITING
The Hague
UMC Utrecht
NOT_YET_RECRUITING
Utrecht
Gelre Ziekenhuis Zutphen
NOT_YET_RECRUITING
Zutphen
New Zealand
Christchurch Hospital
NOT_YET_RECRUITING
Christchurch
Momentum Clinical Research Dunedin
RECRUITING
Dunedin
NZ Respiratory and Sleep Institute
RECRUITING
Greenlane East
Waikato Hospital
NOT_YET_RECRUITING
Hamilton
Momentum Clinical Research
NOT_YET_RECRUITING
Mount Cook
Middlemore Clinical Trials
NOT_YET_RECRUITING
Papatoetoe
Momentum clinical Research Tauranga
RECRUITING
Tauranga
Philippines
Iloilo Doctors Hospital
NOT_YET_RECRUITING
Iloilo City
West Visayas State University Medical Center
NOT_YET_RECRUITING
Iloilo City
Health Cube Medical Clinics
NOT_YET_RECRUITING
Mandaluyong
Quirino Memorial Medical Center
NOT_YET_RECRUITING
Quezon City
Philippine General Hospital
NOT_YET_RECRUITING
Taft, Manila
Poland
Respiratory Medicine Centre, private prac., Bialystok
NOT_YET_RECRUITING
Bialystok
M2M Med Sp. z o.o. sp. j.
NOT_YET_RECRUITING
Chorzów
Screenmed Sp. z o.o.
NOT_YET_RECRUITING
Piaseczno
EMED, Center of Medical Services,Private Prac,Rzeszow
NOT_YET_RECRUITING
Rzeszów
Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski
NOT_YET_RECRUITING
Warsaw
Medical Center K2J2
NOT_YET_RECRUITING
Wołomin
Portugal
ULS da Região de Aveiro
NOT_YET_RECRUITING
Aveiro
ULS Braga
NOT_YET_RECRUITING
Braga
ULS de Coimbra, E.P.E.
NOT_YET_RECRUITING
Coimbra
ULS do Alto Ave
NOT_YET_RECRUITING
Guimarães
ULS da Região de Leiria, E.P.E.
NOT_YET_RECRUITING
Leiria
ULS de Santa Maria, E.P.E
NOT_YET_RECRUITING
Lisbon
ULS de São João
NOT_YET_RECRUITING
Porto
ULSAM - Hospital de Santa Luzia
NOT_YET_RECRUITING
Viana Do Castelo
ULS de Gaia/Espinho, EPE
NOT_YET_RECRUITING
Vila Nova De Gaia
Puerto Rico
San Juan Bautista School of Medicine
NOT_YET_RECRUITING
Caguas
Office of Ricardo Fernandez-Gonzalez, MD
NOT_YET_RECRUITING
San Juan
VA Caribbean Healthcare System
NOT_YET_RECRUITING
San Juan
Republic of Korea
Hallym University Sacred Heart Hospital
NOT_YET_RECRUITING
Anyang
Chungbuk National University Hospital
NOT_YET_RECRUITING
Chungju
Yeongnam University Hospital
NOT_YET_RECRUITING
Daegu
Ulsan University Hospital
NOT_YET_RECRUITING
Dong-gu Ulsan
The Catholic University of Korea, Incheon St. Mary's Hospital
NOT_YET_RECRUITING
Incheon
Asan Medical Center
NOT_YET_RECRUITING
Seoul
Hallym University Kangnam Sacred Heart Hospital
NOT_YET_RECRUITING
Seoul
Hanyang University Medical Center
NOT_YET_RECRUITING
Seoul
Jeonbuk National University Hospital
NOT_YET_RECRUITING
Seoul
Kangdong Sacred Heart Hospital
NOT_YET_RECRUITING
Seoul
Konkuk University Medical Center
NOT_YET_RECRUITING
Seoul
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Severance Hospital
NOT_YET_RECRUITING
Seoul
SMG-SNU Boramae Medical Center
NOT_YET_RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
The Catholic University of Korea, Seoul St.Mary's Hospital
NOT_YET_RECRUITING
Seoul
Yonsei University Wonju Severance Christian Hospital
NOT_YET_RECRUITING
Wŏnju
Romania
Marius Nasta Institute of Pneumophthisiology
NOT_YET_RECRUITING
Bucharest
Clinical Hospital of Pneumophysiology Leon Daniello
NOT_YET_RECRUITING
Cluj-napoca
SC Medlife S.A
NOT_YET_RECRUITING
Cluj-napoca
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara
NOT_YET_RECRUITING
Timișoara
Serbia
University Clinical Center of Serbia
NOT_YET_RECRUITING
Belgrade
Institute for Pulmonary Diseases of Vojvodina
NOT_YET_RECRUITING
Kamenitz
University Clinical Center of Kragujevac
NOT_YET_RECRUITING
Kragujevac
University Clinical Center Nis
NOT_YET_RECRUITING
Niš
Health Center Uzice
NOT_YET_RECRUITING
Užice
Singapore
Changi General Hospital
NOT_YET_RECRUITING
Singapore
National University Hospital-Singapore-42005
NOT_YET_RECRUITING
Singapore
Singapore General Hospital
NOT_YET_RECRUITING
Singapore
Tan Tock Seng Hospital
NOT_YET_RECRUITING
Singapore
Slovakia
Zeleznicna Hospital Kosice
NOT_YET_RECRUITING
Košice
Univ. Hospital Martin
NOT_YET_RECRUITING
Martin
Plucna ambulancia Hrebenar s.r.o.
NOT_YET_RECRUITING
Spišská Nová Ves
South Africa
Iatros International
NOT_YET_RECRUITING
Bloemfontein
Dr Ismail Abdullah
NOT_YET_RECRUITING
Cape Town
Addington Hospital
NOT_YET_RECRUITING
Durban
Charlotte Maxeke Hospital
NOT_YET_RECRUITING
Johannesburg
Enhancing Care Foundation NPC
NOT_YET_RECRUITING
Mount Edgecombe
CAPRISA Offices on the King DinuZulu Hospital Complex
NOT_YET_RECRUITING
Springfield
Spain
Hospital A Coruña
NOT_YET_RECRUITING
A Coruña
Hospital Germans Trias i Pujol
NOT_YET_RECRUITING
Badalona
Hospital Clínic de Barcelona
NOT_YET_RECRUITING
Barcelona
Hospital Universitari Vall D Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Virgen de la Arrixaca
NOT_YET_RECRUITING
El Palmar
Hospital Universitari de Girona Doctor Josep Trueta
NOT_YET_RECRUITING
Girona
Hospital Infanta Elena
NOT_YET_RECRUITING
Huelva
Hospital Jerez de la Frontera
NOT_YET_RECRUITING
Jerez De La Frontera
Hospital de Bellvitge
NOT_YET_RECRUITING
L'hospitalet De Llobregat
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital de Mérida
NOT_YET_RECRUITING
Mérida
Hospital Central de Asturias
NOT_YET_RECRUITING
Oviedo
Hospital Son Espases
NOT_YET_RECRUITING
Palma De Mallorca
Complejo Hospitalario de Navarra
NOT_YET_RECRUITING
Pamplona
Hospital Quirónsalud Madrid
NOT_YET_RECRUITING
Pozuelo De Alarcón
Hospital Universitario Puerto Real
NOT_YET_RECRUITING
Puerto Real
Hospital Universitario Marqués de Valdecilla
NOT_YET_RECRUITING
Santander
Complexo Hospitalario Universitario De Santiago
NOT_YET_RECRUITING
Santiago De Compostela
Hospital Virgen del Rocío
NOT_YET_RECRUITING
Seville
Hospital Virgen Macarena
NOT_YET_RECRUITING
Seville
Hospital Politècnic La Fe
NOT_YET_RECRUITING
Valencia
Sweden
Universitetssjukhuset, Örebro
NOT_YET_RECRUITING
Örebro
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
CTC Clinical Trial Consultants AB
NOT_YET_RECRUITING
Uppsala
Switzerland
Universitätsspital Basel
NOT_YET_RECRUITING
Basel
University Hospital of Lausanne
NOT_YET_RECRUITING
Lausanne
Taiwan
Kaohsiung Chang Gung Memorial Hospital
NOT_YET_RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
NOT_YET_RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
NOT_YET_RECRUITING
Taichung
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Chang Gung Memorial Hospital Linkou
NOT_YET_RECRUITING
Taoyuan District
National Taiwan University Hospital Yun-Lin Branch
NOT_YET_RECRUITING
Yunlin County
Thailand
Ramathibodi Hospital
NOT_YET_RECRUITING
Bangkok
Siriraj Hospital
NOT_YET_RECRUITING
Bangkok
Srinagarind Hospital
NOT_YET_RECRUITING
Khon Kaen
Songklanagarind Hospital
NOT_YET_RECRUITING
Songkhla
King Chulalongkorn Memorial Hospital
NOT_YET_RECRUITING
Thailand
Turkey
Ankara University Medical Faculty
NOT_YET_RECRUITING
Ankara
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
NOT_YET_RECRUITING
Ankara
Akdeniz Universitesi Tip Fakultesi
NOT_YET_RECRUITING
Antalya
Adnan Menderes Üniversitesi
NOT_YET_RECRUITING
Aydin
Istanbul University Medical Faculty Capa Hospital
NOT_YET_RECRUITING
Istanbul
Marmara University Pendik Training and Research Hospital
NOT_YET_RECRUITING
Istanbul
Manisa Celal Bayar Üniversitesi Tıp Fakültesi
NOT_YET_RECRUITING
Manisa
Mersin University Research and Training Hospital Chest Diseases Department
NOT_YET_RECRUITING
Yenişehir
United Kingdom
Belfast City Hospital
NOT_YET_RECRUITING
Belfast
Heartlands Hospital
NOT_YET_RECRUITING
Birmingham
Blackpool Victoria Hospital
NOT_YET_RECRUITING
Blackpool
Bradford Royal Infirmary
NOT_YET_RECRUITING
Bradford
Velocity Clinical Research, Bristol
NOT_YET_RECRUITING
Bristol
Royal Papworth Hospital
NOT_YET_RECRUITING
Cambridge
University Hospital Llandough
NOT_YET_RECRUITING
Cardiff
Ninewells Hospital & Medical School
NOT_YET_RECRUITING
Dundee, Scotland
University Hospital Hairmyres
NOT_YET_RECRUITING
East Kilbride
Royal Infirmary of Edinburgh
NOT_YET_RECRUITING
Edinburgh
Western General Hospital
NOT_YET_RECRUITING
Edinburgh
Freeman Hospital
NOT_YET_RECRUITING
High Heaton
Royal Lancaster Infirmary
NOT_YET_RECRUITING
Lancaster
St James's University Hospital
NOT_YET_RECRUITING
Leeds
Liverpool Heart & Chest Hospital
NOT_YET_RECRUITING
Liverpool
King's College Hospital
NOT_YET_RECRUITING
London
Royal Brompton Hospital
NOT_YET_RECRUITING
London
Craigavon Area Hospital
NOT_YET_RECRUITING
Portadown
Northern General Hospital
NOT_YET_RECRUITING
Sheffield
Southampton General Hospital
NOT_YET_RECRUITING
Southampton
Royal Stoke University Hospital
NOT_YET_RECRUITING
Stoke-on-trent
Torbay Hospital
NOT_YET_RECRUITING
Torquay
Viet Nam
National Lung Hospital
NOT_YET_RECRUITING
Hanoi
Cho Ray Hospital
NOT_YET_RECRUITING
Ho Chi Minh City
Nhan Dan Gia Dinh Hospital
NOT_YET_RECRUITING
Ho Chi Minh City
University Medical Center HCMC
NOT_YET_RECRUITING
Ho Chi Minh City
Contact Information
Primary
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2028-10-12
Participants
Target number of participants: 1680
Treatments
Experimental: Treatment arm
Placebo_comparator: Placebo arm
Related Therapeutic Areas
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov